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Methotrexate therapy in primary biliary cirrhosis.
1División Gastroenterología, Hospital de Clínicas José de San Martín, Universidad de Buenos Aires.
Acta Gastroenterologica Latinoamericana
|November 22, 2000
Summary
Low-dose oral methotrexate (MTX) did not show significant benefits for primary biliary cholangitis (PBC) patients. While some symptoms improved, liver histology did not consistently benefit, and some patients experienced disease progression.
Area of Science:
- Hepatology
- Immunology
- Pharmacology
Background:
- Primary biliary cholangitis (PBC) is a chronic autoimmune liver disease.
- Current treatments aim to slow disease progression and manage symptoms.
- The efficacy of methotrexate (MTX) as a monotherapy for PBC requires further investigation.
Purpose of the Study:
- To evaluate the therapeutic effect of low-dose oral methotrexate (MTX) in patients with primary biliary cholangitis (PBC).
- To assess changes in liver function tests and histological parameters after MTX treatment.
Main Methods:
- A 2-year open-label study involving 16 female PBC patients (mean age 51.16 years).
- Patients received 15 mg of oral MTX weekly.
- Liver biopsies were performed at baseline and after 2 years; liver function tests were monitored throughout.
Main Results:
- Fourteen patients completed the study; two withdrew due to adverse events (hepatocellular dysfunction, fatigue, interstitial pneumonitis).
- Pruritus resolved in 50% of symptomatic patients; liver enzyme levels showed a significant decline in Alkaline Phosphatase (ALP).
- Liver histology improved in only 18.7% of patients, with 50% showing disease progression, including 4 cases of cirrhosis.
Conclusions:
- Low-dose oral methotrexate is not supported as a monotherapy for PBC.
- The observed disease progression in some patients warrants caution when considering MTX for PBC treatment.